FDA 483 - Gadal Laboratories Inc. - April 28, 2016

An FDA inspection of Gadal Laboratories Inc., an OTC drug manufacturer in Miami, FL, revealed significant deficiencies across its production, quality, and materials systems. The firm lacked validated manufacturing processes, analytical methods, and cleaning procedures, and failed to adequately review discrepancies or conduct required annual product reviews. Additionally, the purified water system was not routinely tested for conformance, indicating a broad failure to ensure drug product quality and purity.